Johnson & Johnson's experimental diabetes drug might bring minor heart risks because it raised cholesterol levels in patient testing, according to federal drug reviewers.
In documents released Tuesday, Food and Drug Administration staff experts conclude studies showed J&J's canagliflozin raised levels of LDL, or bad cholesterol, and slightly increased risk of heart attack, stroke or death, compared to two other types of diabetes medications.
Data from nine large patient studies also showed the pill increased risks of urinary tract infections and fungal infections in the genital area. That's because canagliflozin works by boosting blood sugar excretion via urine, and germs thrive on that sugar.
The studies didn't find other serious problems, such as weakening of bones, damage to the liver or kidneys, or various cancers.
Outside advisers to the FDA will review the data during a meeting Thursday and recommend whether the agency should approve canagliflozin.
If the FDA approves the New Brunswick, N.J., company's drug, it would be the first in a new class of Type 2 diabetes medicines, called SGLT2 inhibitors.
The agency rejected another experimental drug in the SGLT2 class, dapagliflozin from partners Bristol-Myers Squibb Co. and AstraZeneca PLC, a year ago. The FDA cited concerns about possible liver damage and elevated rates of bladder and breast cancer.
In recent years, the FDA has required companies developing diabetes drugs to track cardiac side effects in patient testing. That's because diabetes medicines are taken daily for many years, and one former blockbuster, Avandia, was linked to higher heart attack risks. In 2010, the FDA restricted Avandia's use to patients not helped by any other diabetes treatments, and European regulators barred all sales of Avandia.
The FDA has set a target date of March 31 to decide whether to approve U.S. sales of canagliflozin. Johnson and Johnson would sell it under the brand name Invokana.
Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma.
- Pharmaceuticals & Drug Trials